BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE MANUAL WHEELCHAIR

    MDR report key: 1073662 · Received July 9, 2008

    Report

    Report Number
    1525712-2008-00062
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 7, 2008
    Manufacturer
    INVACARE CORPORATION - MANUFACTURING FACILITY
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME. PHOTOS WERE PROVIDED AND REVIEWED. ENGINEERING REPORTS, BASED ON PHOTO'S PROVIDED THAT THE FORK STEM NUT LOOSENED AND FELL OFF. NOTHING APPEARS BROKEN AND BASED ON THE PHOTOS, IT APPEARS THE DEVICE WASN'T PROPERLY MAINTAINED.

    Description of Event or Problem · 1

    THE FRONT CASTER AND FORK ALLEGEDLY CAME OFF THE WHEELCHAIR, CAUSING THE CONSUMER TO FALL OVER AND HIT HIS LEFT STUMP, CAUSING IT TO BLEED. USER REPORTEDLY WAS ALLEGEDLY ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE MANUAL WHEELCHAIR 890.3850 IOR INVACARE CORPORATION - MANUFACTURING FACILITY 9XDT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention